Formulating better medicines for children Meeting the needs of the children

10 th conference of the European Paediatric Formulation Initiative

A conference organised by the International Association for Pharmaceutical Technology (APV) in partnership with the European Paediatric Formulation Initiative (EuPFI)

11 - 13 September 2018 · Course No. 6729

BMA House, ,

Preconference Workshops

Workshop 1: Placeboceutical: Formulation challenges in paediatric clinical trials

Workshop 2: Best practices for selection of excipients for paediatrics Soap box sessions – Poster session – Exhibition

Join us again for another informative and interactive conference on formulating better medicines for children.

International Association for Pharmaceutical Technology Formulating better medicines for children Meeting the needs of the children

Programme Wednesday, 12 September 2018, 08:30 - 18:30

PRECONFERENCE WORKSHOP Set-up and poster mounting Tuesday, 11 September 2018, 14:30 - 18:00 Welcome and Introduction Workshop 1: Placeboceutical: Formulation challenges Catherine Tuleu, University College London, School of in paediatric clinical trials , United Kingdom Mandy Wan, NIHR CRN: Children, United Kingdom Sandra Klein, Ernst Moritz Arndt University Greifswald, Ger - many

Workshop 2: Best practices for selection of excipients for paediatrics PLENARY 1: 10yrs of EuPFI - historical review and a Kevin Hughes, Colorcon, IPEC, United Kingdom prospective glance Catherine Tuleu, University College London, School of Moderators: Pharmacy, London, United Kingdom Anjali Agarwal - Celgene Corporation, United States David Clapham – Consultant, United Kingdom PLENARY 2: Title to be confirmed soo Smita Salunke – EuPFI, University College London School of Rosalind Smyth, Great Ormond Street Institute of Child Pharmacy, United Kingdom Health, United Kingdom

Swap over and settling PLENARY 3: Title to be confirmed soon Jenny Preston, NIHY, Alder Hey Clinical Research Facility, United Kingdom Workshop 1: Best practices for selection of excipients for paediatrics Kevin Hughes, Colorcon, IPEC, United Kingdom Morning break, exhibition and poster presentations

Moderators: Anjali Agarwal - Celgene Corporation, United States QUESTION TIME: a round table led children and young David Clapham – Consultant, United Kingdom people with patients/carers, industry, academia and Smita Salunke – EuPFI, University College London School of regulators Pharmacy, United Kingdom Focus Session: Age appropriateness of formulations Workshop 2: Placeboceutical: Formulation challenges Chair: Fiona O’Brien, Royal College of Surgeons in Ireland, in paediatric clinical trials Ireland Mandy Wan, NIHR CRN: Children, United Kingdom Swallowability Studies in the Real World – Challenges and Successes Matthew Peak, Alder Hey Children's NHS Foundation Trust, United Kingdom Wrap-up and discussion

Age-Appropriate Formulations – 10 yrs down the lane - Terry Ernest, GlaxoSmithKline, United Kingdom Social event starting at 20:00 h

Discussion

Lunch, exhibition and poster presentations

Programme is subject to change Soapbox Session I Thursday, 13 September 2018, 08:30-16:00

PLENARY 4: Milk as an excipient – new insights into Brief introduction Day 2 / Housekeeping nanostructure formation during digestion and drug Catherine Tuleu, University College London, School of Phar - delivery macy, United Kingdom Ben Boyd, Monash University, Australia Sandra Klein, Ernst Moritz Arndt University Greifswald, Germany

Afternoon break, exhibition and poster presentations PLENARY 5: International chapter on paediatric for - mulations: Pediatrics in global health from BMGF’s Focus session: Administration devices perspective Chair: Jenny Walsh, Jenny Walsh Consulting Ltd., Niya Bowers, Bill & Melinda Gates Foundation, United States United Kingdom Focus session: Excipients Chair: Smita Salunke, University College London, School of Pediatric Dosing Device Contextual Inquiry Pharmacy, EuPFI, United Kingdom Paul Blowers, AbbVie, United States Katie Hansbro, Design Science, United States Novel excipients in paediatrics Johann-Philipp Hebestreit, BASF Novel polymeric microneedle platforms and their potential impact on paediatric population Aaron Courtenay, Queens University Belfast, Practical regulatory approach on excipients in paediatrics United Kingdom Brian Aylward, Health Products Regulatory Authority, Dublin

Discussion Discussion

Soapbox Session II Soapbox Session III

Morning break, exhibition and poster presentations Focus Session: Biopharm Chair: Hannah Batchelor, University of Birmingham, UK Innovation Showcase

Paediatric drug development: towards maturity. Desmopressin as a case Case Studies Elke Gasthuys, Ghent University, Belgium

Announcement of PCCA winners/Travel award winners Challenges in formulation development of a com - pound indicated for paediatric infectious disease Lunch, exhibition and poster presentations Jens Ceulemans, Janssen, Belgium

PLENARY 6: Collaborative R&D (SPaeDD-UK) - "playing Discussion nicely in the sandpit!" Alastair Coupe, Pfizer, United Kingdom

Housekeeping Focus Session: Taste masking and taste testing Chair: David Clapham – Consultant, United Kingdom

An industrial point of view on palatability testing and Social Evening - A special dinner/sightseeing cruise paediatric development with musical entertainment and dinner buffet Leonie Wagner-Hattler, Roche, Switzerland

Crossmodal Research and emerging technologies digi - tizing senses – what is the learning for pharma? Charles Spence, University of Oxford, United Kingdom

Discussion

Conference Wrap-up and discussion

Programme is subject to change Important Dates Important dates and call for abstracts – 30 May 2018 submission deadline for oral and poster presentations Notification of acceptance – 03 July 2018 Conference early bird registration – 15 July 2018 For more information go to www.eupfi.org

Topics for oral and poster presentations

1. Excipients 2. Taste assessment and taste masking 3. Administration devices 4. Age appropriateness of Formulations 5. Formulating paediatric medicines for developing countries 6. Lessons learned from PIP submissions 7. Biopharmaceutics Awards

new on occasion of 10th anniversary conference EuPFI Young Scientist Travel Award To help students, and early career researchers, to attend and present their research at EuPFI conference. Award: To provide up to 3 awards as a contribution towards the cost of accommodation/meals at the conference/cost of travel to and from the conference, up to a maximum grant of £500. Application deadline: 30th May 2018 See website for specific details/more information: www.eupfi.org

As usual we have 4 awards (3poster and 1 oral) sponsored by PCCA. See website for specific details/more information: www.eupfi.org Exhibition and Sponsoring

We are glad to tailor a sponsor package (starting from 1000 EUR) according to your wishes. For general information, please go to www.apv-mainz.de/en/seminare/sponsoring-exhibition/

As an exhibitor you will be also invited to attend the sessions and the networking dinner in the evening. At the confe- rence center the poster presentations will again be integrated in the exhibition, ensuring that participants are around the exhibition stands as much as possible. Price for a tabletop space with table, chairs and power supply is 990 EUR plus one mandatory full conference registration (register before 15 July 2018, to take advantage of the early bird fee!).

Please contact Valentina Marinkova Phone +49 6131 9769 40 e-mail [email protected] Date Holiday Inn London Conference Secretariat Coram St, Bloomsbury, London WC1N 1HT Course no. 6729 For organisational questions www.ihg.com/holidayinn/hotels/gb/en/london/lonbl/ from 11 September 2018 14:30 International Association for hoteldetail to 13 September 2018 16:00 Pharmaceutical Technology (APV) For up-to-date information please go to the Kurfuerstenstraße 59 Registration times for workshop participants: respective hotel website. 55118 Mainz, Germany 11 September 2018 14:00 Phone: +49 6131 9769-0 Registration times for conference participants: Location Fax: +49 6131 9769-69 e-mail: [email protected] 12 September 2018 08:00 Preconference workshop venue www.apv-mainz.de University College London Set up and poster mounting times: School of Pharmacy 12 September 2018 08:30 For scientific questions 29-39 Bloomsbury EuPFI Hotel recommendation London WC1N1AX UCL School of Pharmacy Royal National Hotel United Kingdom 29-39 Brunswick square 38-51 Bedford Way, Bloomsbury, London WC1H London WC1N 1AX 0DG, www.imperialhotels.co.uk/en/royal-national Conference venue Phone: +44 20 7753 5846 BMA House Fax : +44 20 7753 5942 Ambassadors Bloomsbury e-mail: [email protected] 12 Upper Woburn Pl, Bloomsbury, London WC1H London WC1H9JP www.eupfi.org 0HX, www.ambassadors.co.uk United Kingdom Mainz, March 2018

Register by 15 July 2018 to take advantage of the early bird fee Early bird Full fee Non-Member (non academic, non governmental) 1225 EUR 1325 EUR Member of EuPFI (non academic, non governmental) 1095 EUR 1195 EUR Non-Member (academic, governmental) 525 EUR 575 EUR Member of EuPFI (academic, governmental) 460 EUR 510 EUR Students (please enclose evidence) 230 EUR 270 EUR Workshop prices additional to registration fee: Non-Member + Member EuPFI (non academic, non governmental) 330 EUR 380 EUR Non-Member + Member of EuPFI (academic, governmental) 180 EUR 205 EUR Students (please enclose evidence) 90 EUR 115 EUR

Do you want to participate in the Workshops: yes no Course no. 6729 Registration Formulating better medicines for children All correspondence regarding the in London , United Kingdom , 11 to 13 September 2018 conference should be addressed to:

APV Title, First Name, Name Kurfuerstenstraße 59 55118 Mainz/Germany Company/institution name Phone: +49 6131 9769-0 Fax: +49 6131 9769-69 e-mail: [email protected] Company/institution address www.apv-mainz.de

You will receive a confirmation of your Phone Fax registration with the invoice. pay via invoice e-mail address participant Order no. pay via credit card (fill in below)

Visa Position in Company/institution Department Mastercard

EuPFI member Non-member Amex

Card holder:______Date Signature Card no.: ______Valid until: ______CVC code: ______